North Carolina judge loosens abortion pill restrictions on doctors

RALEIGH, N.C. (CN) — A North Carolina doctor who sued over abortion pill access for her patients said she is pleased with a ruling that loosens restrictions on the medication.

U.S. District Judge Catherine Eagles ruled Tuesday evening that North Carolina lawmakers overstepped their authority in restricting the abortion pill mifepristone.

North Carolina law bans mifepristone prescriptions via telemedicine, requires patients to receive state counseling before receiving a medication abortion, undergo a 72-hour waiting period, and have the drug administered by a physician in a medical facility. Prescriptions can only be written by physicians, which prevents other qualified medical professionals —  such as nurse practitioners — from prescribing mifepristone. Medical providers that violate these provisions face professional, civil and criminal penalties.

Dr. Amy Brant sued North Carolina Attorney General Josh Stein this past January, claiming that the restrictions created unnecessary burdens on health care providers and reduced patient access. The restrictions also go beyond what is required and recommended by the U.S. Food and Drug Administration guidelines, which approved mifepristone for medication abortion in 2000. 

Timothy Moore and Phil Berger, Republican leaders in the House and Senate, were defendant-intervenors in the suit and argued that without additional state requirements, mifepristone isn’t safe. They also claimed the FDA establishes a “floor” of requirements the states are able to add to. 

In her order, Eagles found North Carolina’s additional safety restrictions “frustrate the congressional goal of establishing a comprehensive regulatory framework under which the FDA determines conditions for safe drug distribution that do not create unnecessary burdens on the health care system or patient access.”

The Barack Obama appointee found requiring in-person prescribing, dispensing and administering are preempted by federal law, as are requirements to schedule an in-person follow-up appointment and provisions mandating doctors report any non-fatal adverse events to the FDA. The excessive requirements “stand as obstacles to Congress’ purpose,” she wrote, also striking down the provision that only physicians can prescribe, dispense, and administer the drug.

“North Carolina cannot second-guess the FDA’s explicit judgment on how to manage risks from and safely prescribe, dispense, and administer REMS drugs, including mifepristone,” Eagles wrote. “The state here is imposing restrictions on who can prescribe a REMS drug and how that drug can be prescribed, dispensed, and administered. Those exact restrictions have been explicitly rejected by the FDA as unnecessary for safe administration and as unnecessary burdens on the health care system and patient access.: 

Bryant said Wednesday that she was pleased with the ruling. In her suit, she argued many of the restrictions lawmakers instituted had been considered, tested, and discarded by the FDA.

"I am pleased that Chief Judge Eagles recognized that North Carolina cannot impose restrictions on an FDA-approved medication that second-guess or interfere with the FDA’s expert judgment,” she said. “We are carefully reviewing the ruling and the implications it has for providing care to patients in North Carolina.”

Eagles allowed several safety restrictions not considered and rejected by the FDA to stand. These include gestational ultrasounds, an in-person 72 hour advance consultation and a physical examination of the woman seeking an abortion, blood type testing, and reporting of adverse events to state health authorities.

These requirements, Eagles found, impose standards of care for obtaining a patient’s informed consent before the procedure. They give physicians the ability to look for signs of abuse and inform the woman of any additional risks related to her blood type before she undergoes a medical or surgical abortion. 

In granting summary judgment in part to both sides, Eagles asked their lawyers to file a joint submission with proposed judgments. 

“North Carolina’s police powers traditionally extend to areas of health, safety, and the medical profession, and, generally speaking, it can legislate in those fields,” she wrote. “But when the FDA has created a (Risk Evaluation and Mitigation Strategies) program for a higher-risk drug and expressly imposed and removed a REMS element, the state cannot reimpose that restriction based on drug safety concerns.” 

Moore and Berger did not respond to a request for comment. 

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